5-Azacitidine and Decitabine Epigenetic Therapy for Myeloid Malignancies

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Benjamin Tomlinson
Study ID
NCT04187703
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • MDS/MPN Crossover Syndromes
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-azacytidine — DRUG
    5-azacytidine 50 mg/m\^2 Day 1 every week ± G-CSF \~5 µg/kg (300µg vs 480µg)
  • Decitabine — DRUG
    Decitabine 5 mg/m\^2 Day 4 every week ± G-CSF \~5 µg/kg (300µg vs 480µg)

Study Details

Another term for myelodysplastic syndrome is bone marrow failure. The bone marrow is where components of blood such as red cells, platelets and white cells are made. In bone marrow failure, the ability for bone marrow to make these cells is decreased. In myelodysplastic syndrome, this decreased bone marrow function is believed to result from abnormalities that prevent the normal maturation process by which bone marrow cells develop into red blood cells, white blood cells and platelets. In myelodysplastic syndrome, these abnormal bone marrow cells occupy space in the bone marrow and prevent the function of remaining normal bone marrow cells. One approach to treating the abnormal growth of immature cells is to give chemotherapy which damages DNA within these cells and causes their death. Unfortunately, such therapy has side-effects, since even normal cells can be affected by the treatment. Both 5-azacitidine (5AZA) and decitabine (DEC) are FDA-approved to treat MDS. In this study, 5AZA and DEC will be administered using an alternating low doses schedule in an attempt to overcome the known mechanisms of resistance to the administration of 5AZA or DEC as single agents caused by automatic adaptive shifts in DNA metabolism.

Key Dates

Start date
Nov 16, 2020
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 5AZA-alt-DEC
    Participants will be treated for a minimum of 24 weeks in the absence of clear evidence of progressive disease. Patients who have any response will be permitted to continue treatment until relapse or progression of disease that is not sensitive to protocol defined dose escalation. Treatments will include: 5-azacytidine (50mg/m\^2) Day 1 every week Decitabine (5mg/m\^2) Day 4 every week Weeks 1-8 will be an induction phase, and weeks 9+ will be a long-term treatment phase

Primary Outcome Measure

Overall response rate (ORR) of 5AZA-alt-DEC [ Time Frame: Up to 6 months from end of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106
Benjamin Tomlinson
[email protected]
+1 216-844-0139

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By research site
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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